Roche Gets FDA Approval for Perjeta Combo for After-Surgery Breast Cancer Treatment
December 21 2017 - 2:24AM
Dow Jones News
By Sonia Amaral Rohter
Roche Holding AG (ROG.EB) said on Thursday that the U.S. Food
and Drug Administration has approved Perjeta in combination with
other treatments for after-surgery treatment of certain types of
breast cancer.
Following the FDA's decision, the Perjeta-based regimen is now
approved for the post-surgery treatment of HER2-positive early
breast cancer at high risk of recurrence.
The Perjeta-based regimen is a combination of Perjeta,
chemotherapy and Herceptin, another Roche cancer drug. The
mechanisms of action of Perjeta and Herceptin are believed to
complement each other, Roche said, to prevent tumor cell growth and
survival.
The regimen had previously been granted FDA approval for
HER2-positive metastatic breast cancer as well as accelerated
approval for pre-surgery use in patients with early stage breast
cancer. Roche said that its accelerated approval for the
pre-surgery use of the Perjeta-based regimen has now been converted
to a full approval.
"Today's approval of Perjeta means people with HER2-positive
early breast cancer at high risk of recurrence have a new,
clinically meaningful treatment option to reduce the chances of
their disease returning," said Sandra Horning, Roche's chief
medical officer and head of global product development.
Write to Sonia Amaral Rohter at
sonia.amaralrohter@dowjones.com
(END) Dow Jones Newswires
December 21, 2017 02:09 ET (07:09 GMT)
Copyright (c) 2017 Dow Jones & Company, Inc.
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